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Sleep, HIV Disease Progression, and Function in HIV Infected Children and Adolescents

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ClinicalTrials.gov Identifier: NCT00253695
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : March 28, 2013
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
William Shearer, Baylor College of Medicine

Brief Summary:
This study is a first step in approaching the gap existing between understanding sleep abnormalities, alterations in sleep-regulating cytokines and HIV-1 disease regulating cytokines, and abnormal higher cortical function.

Condition or disease Intervention/treatment
Sleep HIV Infections Device: Wrist Actigraphy

Detailed Description:


In the growing number of HIV infected youth and young adults, it is important to study the effects of HAART treatment on sleep patterns and related neurocognitive and psychosocial function.

DESIGN NARRATIVE (including primary and secondary outcomes):

Using validated sleep questionnaires and actigraphy measurements, overnight polysomnography (PSG, sleep study) will assess the degree of abnormal sleeping patterns and daytime sleepiness in HIV infected children and HIV uninfected children (control group).

The following peripheral blood levels will be measured over a 24-hour period, at multiple time points, in all participants: TNF-alphaRI and IL-6 (sleep-regulating cytokines); IFN-gamma and IL-12 (cytotoxic or TH1 cytokines); and IL-10 and IL-1RA (inflammatory or TH2 cytokines). This will help to determine the association between alterations in sleep-regulating cytokines and HIV disease progression (CD4+ T-cell count, HIV-1 RNA level).

Neurocognitive and neuropsychological tests will be performed on all participants to determine if there is an association between lack of normal sleeping habits, alterations in sleep-regulating cytokines and HIV-1 disease progression cytokines, and neurocognitive/neuropsychological performance.

Computer analysis of electroencephalography (EEG) will be performed during wakefulness and all stages of sleep to determine if greater disease severity, sleepiness, sleep disruption, and neurocognitive impairment is associated with increased amounts of slow activity. Improvement in these related factors will be associated with normalizations of these parameters. For some of these quantitative measures, the findings may be more significant for particular brain regions; for example, frontal regions in the case of attention problems.

Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Sleep Studies in HIV+ Older Children/Adolescents
Study Start Date : July 2004
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Intervention Details:
    Device: Wrist Actigraphy
    Wrist actigraph will record participants' sleeping patterns.

Primary Outcome Measures :
  1. Association of cytokines, sleep patterns, and neurocognitive function in youth with HIV. [ Time Frame: 11/2005 - 02/2009 ]
    Observational study only

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
HIV-infected children with and without asthma.

Inclusion Criteria:

HIV Group

  • HIV-1 infection

Control Group

  • Family members and friends of HIV-1 infected children

Exclusion Criteria:

HIV Group

  • Pregnancy

Control Group

  • Pregnancy
  • Asthma
  • Sleep apnea

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253695

United States, Texas
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: William Shearer, MD, PhD Texas Children's Hospital/Baylor College of Medicine

Foster SB, Paul ME, Glaze DG, Reuben JM, Harris LL, Cohen EN, Lee B-N, Kozinetz CA, Schwarzwald HL, Kline MW, Jackson CD, Loeb AJ, Frerking PR, Brouwers PY, Shearer WT. Viremia is associated with sleep disturbances, neurocognitive disorders and cytokine dysregulation in pediatric HIV infection. J Allergy Clin Immunol 2007;119;S232.
Lipshultz SE, Fisher SD, Sharma T, Milton A, Miller TL. HIV-associated cardiovascular disease. Dialogues in Cardiology 2007, in press.

Responsible Party: William Shearer, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00253695     History of Changes
Other Study ID Numbers: 1317
R01HL079533 ( U.S. NIH Grant/Contract )
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases